Humalog® Mix50/50(tm) as a Treatment for Gestational Diabetes
Phase 4 Humalog® Mix50/50(tm) for the Treatment of Insulin Requiring Gestational Diabetes
  • Phase

    Phase 4
  • Study Type

  • Study Participants

Evaluation of the Safety and Efficacy of Humalog® Mix50/50TM administered as 3 injections daily to Humalog® plus Humulin N® insulin administered as 6 separate injections daily in terms of glucose control for women with Gestational Diabetes.
Controlling hyperglycemia during pregnancy decreases the risk of adverse neonatal and maternal outcomes. Not only must fasting glucose be normalized, but clinical evidence also indicates that controlling postprandial hyperglycemia will significantly reduce the risk of adverse neonatal and maternal outcomes.

Standard therapy to achieve near-normal glycemia in gestational diabetes involves combining intermediate-acting basal (NPH) insulin with rapid-acting insulin (insulin lispro), thereby requiring 6 daily injections. Premixed Humalog® Mix50/50TM has the potential advantage over combination rapid-acting plus NPH insulin because it involves fewer injections, and those injections are associated with mealtime. The potential downside to the premixed formulation is nocturnal hypoglycemia associated with the time lag between the dinner and breakfast dose. This study will evaluate the efficacy and safety of Humalog® Mix50/50TM compared to that of Humalog® plus Humulin N® insulin for the treatment of insulin-requiring patients with gestational diabetes mellitus, while monitoring glucose control, intrauterine growth and assessing pregnancy outcomes.
Study Started
Oct 31
Primary Completion
Jun 30
Study Completion
Oct 31
Results Posted
Jun 08
Last Update
Jun 08

Drug Insulin LISPRO

Humalog® Mix50/50™ [50% insulin lispro protamine suspension and 50% insulin lispro injection, (rDNA origin)], three times daily at mealtime. Dose determined by blood glucose history.

  • Other names: Humalog® Mix50/50™

Drug Insulin, Long-Acting and Insulin

Usual insulin regimen: Long-acting insulin three times daily on rising, mid-afternoon, and before bed, and insulin lispro three times daily at mealtime. Doses determined by blood glucose history and carbohydrate content of the meal.

  • Other names: Humalin N(r), Humalog (r)

Mix 50/50 Experimental

Insulin LISPRO: 3 doses of Humalog® Mix50/50™ at mealtime.

Usual insulin regimen Active Comparator

Usual insulin regimen of insulin, Long-Acting and Insulin: 3 injections of Humalog(r) daily with meals; 3 injections of Humulin N (r) daily on rising, mid-afternoon, and at bedtime


Inclusion Criteria:

Pregnant and at least 13 weeks gestation
Diagnosed with gestational diabetes mellitus
Failed diet therapy

Exclusion Criteria:

<18 years old or over 45 years old
urine dipstick >2+ protein
blood pressure >140/80 mmHg
hematocrit <30%
refusal to take insulin
inability to understand instructions or to consent to participate.


Mix 50/50

Usual Insulin Regimen

All Events

Event Type Organ System Event Term Mix 50/50 Usual Insulin Regimen

Hemoglobin A1C

Compare the efficacy and safety of three daily injections of Humalog® Mix50/50TM to six daily injections of Humalog® and Humulin N® insulin, by hemoglobin A1C.

Mix 50/50

A1c percent (Mean)
Standard Deviation: 0.3

Usual Insulin Regimen

A1c percent (Mean)
Standard Deviation: 0.3

Birthweight of Infant

Birthweight of infant born to mother with gestational diabetes using insulin

Mix 50/50

grams (Mean)
Standard Deviation: 519

Usual Insulin Regimen

grams (Mean)
Standard Deviation: 419



Age, Continuous

years (Mean)
Standard Deviation: 4.65

Age, Categorical

Region of Enrollment

Sex: Female, Male

Overall Study

Mix 50/50

Control Group: Usual Insulin Regmien